Pharmakon Recalls Magnesium Sulfate Injection Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 10 bags of Magnesium Sulfate 1GM in 0.9% Sodium Chloride due to a lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating (score 4) under the rubric, particularly given the risk of serious injury from non-sterile injectable products.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 10 bags of Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only. The product is compounded by Pharmakon Pharmaceuticals in Noblesville, Indiana, and carries the NDC 45183-0803-41.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify a particular contamination event or pathogen, but indicates that the sterility of the product cannot be guaranteed.
The affected product was distributed nationwide, including to VA/DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates. Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions.
The recalled product
- Product
- Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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